This invention relates to a new and improved angioplasty device for compressing and/or removing atherosclerotic plaques, thromboses, stenoses, occlusions, clots, potential embolic material and so forth (hereinafter "obstructions") from veins, arteries, vessels, ducts and the like (hereinafter "vessels"). The device also has potential for treatment of the following conditions or performance of the following procedures, among others: congenital or acquired stenoses or obstructions; percutaneous aspiration thromboembolectomy; cerebral embolization; congenital or acquired obstruction or stenosis of the aorta, renal, coronary, pulmonary, iliac, femoral, popliteal, peroneal, dorsalis pedis, subclavian, axillary, brachial, radial, ulnar, vertebral, cerebral and/or cerebellar artery or any other accessible artery or their ramifications; congenital or acquired obstruction or stenosis of the superior vena cava, inferior vena cava, common iliac, internal iliac, external iliac, femoral, greater saphenous, lesser saphenous, posterior tibial, peroneal, popliteal, pulmonary, coronary, coronary sinus, innominate, brachial, cephalic, basilic, internal jugular, external jugular, cerebral, cerebellar, sinuses of the dura mater and/or vertebral vein or any other accessible vein or their ramifications; atheromatous lesions of any graft or its ramifications; obstructions or stenoses of connections between and among grafts, vains, arteries, organs and ducts; vena caval bleeding; congenital or acquired intracardiac obstructions, stenoses, shunts and/or aberrant communications; congenital or acquired cardiovascular obstructions, stenoses and/or diseases; infusion of thrombolytic agents; thromboembolic phenomena; diagnostic catheterization; removal of clots; intrahepatic and/or extrahepatic biliary ductal obstructions (e.g., stones, sediment or strictures); intravascular, intracardiac and/or intraductal foreign bodies; renal dialysis; congenital and acquired esophageal and/or gastrointestinal obstructions and/or stenoses; non-organized atheromata; dialysis fistula stenosis; ruptured cerebral aneurysm; arterio-arterial, arteriovenous and/or veno-venous fistulae; ureteral obstructions obstructions (e.g., stones, sediment or strictures); fibromuscular dysplasia of the renal artery, carotid artery and/or other blood vessels; and/or atherosclerosis of any accessible artery, vein or their ramifications. Such procedures may be performed in both humans and other applications.
As used throughout this specification and the claims "angioplasty" shall not be restrictive and shall refer to (1) any of the medical and/or veterinary procedures and treatments described in the preceding paragraph, (2) procedures and treatments similar to those described in the preceding paragraph, and (3) any other treatment or procedure involving the removal of an obstruction from vessels or vessel-like structures, regardless of whether such structures are part of or associated with a living organism. It may be obvious to those skilled in fields of art apart from the art of angioplasty devices and procedures that the instant invention could be applied to remove obstructions from "non-living" tubes, tubules, conduits, fibers or other structures (also hereinafter "vessels") in non-medical or industrial applications. For example, a device of the invention could be used to remove an obstruction from a fluid delivery tube within a machine under conditions where it would be undesirable for particles of the obstruction to break free and continue down the tube, e.g., if the machine were still running and particles would jeopardize continued operation. The term "angioplasty" as used throughout this specification and the appended claims is intended to encompass any such applications.
Prior art devices, representing the traditional angioplasty device, are basically a catheter containing a balloon-like member which is inserted into the occluded vessel. Expansion of the balloon at the obstruction site crushes the obstruction against the interior lining of the vessel. When the balloon is retracted, the obstruction remains pressed against the vessel wall and the effective diameter of the vessel through which fluid may flow is increased at the site of the obstruction. The traditional angioplasty device incorporating a balloon is represented by U.S. Pat. Nos. 4,646,742, 4,636,195, 4,587,975 and 4,273,128.
Angioplasty devices have also been developed incorporating expandable meshes or braids, U.S. Pat. Nos. 4,650,466 and 4,572,186, drilling or cutting members, U.S. Pat. Nos. 4,631,052, 4,589,412 and 4,445,509, and lasers, U.S. Pat. Nos. 4,641,912 and 4,576,177, as the means for crushing or removing an obstruction.
Many problems have been associated with all types of angioplasty devices. Perhaps the most significant problem is the creation of particulate matter during the obstruction removal procedure. These particles are released into the fluid flowing through the vessel and can lead to emboli, clots, stroke, kidney failure, heart failure, gangrene, tissue injury, tissue death, emergency bypass surgery, death and other undesirable side effects and complications.
It would be desirable to provide an angioplasty device that prevents substantially all physiologically significant particles from escaping from the obstruction site, thus preventing the occurrence of unfavorable side effects from angioplasty treatment and procedures.